A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

March 26, 2014 updated by: US Department of Veterans Affairs
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center HSR&D COE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have a VA medical center primary care provider;
  • Failed first line diet and exercise recommendations;
  • In stable health by screening physical and lab tests;
  • Agrees to make regular visits per study protocol;
  • Has access to telephone;
  • Body mass index (BMI) > or = 27 with obesity-related illness OR BMI > or = 30 with no risk factors;
  • No contraindications to Orlistat;
  • Not pregnant or breast-feeding;
  • No serious mental health illness such as dementia or schizophrenia;
  • No use of a weight loss therapy in the month prior to screening.

Exclusion Criteria:

  • No VAMC primary care provider
  • Unable to attend regular study visits
  • No access to telephone
  • BMI < 27
  • Contraindications to Orlistat
  • Pregnancy, breast feeding or planning to become pregnant
  • Unstable mental health illness
  • Use of a weight loss therapy in the month prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Carbohydrate Ketogenic Diet
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Behavioral: Low carbohydrate ketogenic diet
A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
Active Comparator: Low-Fat Diet plus Orlistat
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.
Drug: Orlistat
In addition to the low fat diet, Orlistat is taken 3 times daily.
Other Names:
  • Xenical
Behavioral: Low-fat diet
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight at 48 Weeks
Time Frame: baseline and 48 weeks
Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.
baseline and 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks
Time Frame: baseline and 48 weeks
Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.
baseline and 48 weeks
Change From Baseline in Blood Sugar at 48 Weeks
Time Frame: Baseline and 48 weeks
Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.
Baseline and 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: William S. Yancy, MD MHS, Durham VA Medical Center HSR&D COE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 15, 2005

First Submitted That Met QC Criteria

April 15, 2005

First Posted (Estimate)

April 18, 2005

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-005-03F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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